Orthovita, Inc. (VITA)

[Pennyland]

Orthovita Notes Publication by The Lancet of Study Demonstrating Efficacy of Vertebroplasty vs. Conservative Treatment

2010-08-11 15:01 CT - News Release

* First large multicenter prospective study comparing efficacy of vertebroplasty to optimized conservative care in the treatment of acute vertebral compression fractures
* In the 202-patient randomized study, vertebroplasty resulted in greater pain relief than conservative treatment at all timepoints
* No serious complications or adverse events were reported


Company Website: http://www.orthovita.com
MALVERN, Pa. -- (Business Wire)

Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, notes that the August 10, 2010 online edition of The Lancet includes the largest peer-reviewed study to date demonstrating the efficacy of vertebroplasty in the treatment of acute vertebral compression fractures compared to conservative treatment. The article, titled “Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open label randomised trial,” was authored by Drs. Klazen and Lohle et al and described the methods and findings of a 202-patient study conducted in the Netherlands and Belgium between October 1, 2005 and June 30, 2008.

Vertebroplasty is a minimally invasive procedure involving the percutaneous injection of bone cement into a fractured vertebral body, effectively reducing pain. Orthovita received FDA clearance in June 2009 for Cortoss™ Bone Augmentation Material, a synthetic biomaterial, for use in vertebroplasty as an alternative to polymethylmethacrylate (PMMA) bone cement. Although PMMA and not Cortoss was used in the Vertos II study, in a 256-patient IDE vertebral augmentation study submitted to the FDA, Cortoss demonstrated non-inferiority to PMMA and statistically significant superiority in pain relief at 3 months and mobility at 24 months. In August 2009, the New England Journal of Medicine published two studies which seemed to indicate that a “sham” procedure and vertebroplasty were equally effective. According to the Vertos II investigators, the clinical interpretation of the NEJM studies is thwarted by the inclusion of patients with subacute and chronic fractures instead of acute fractures, and other methodological issues. The stated intention of the investigators in the Vertos II study was therefore “to clarify whether percutaneous vertebroplasty has additional value compared with optimum pain treatment in a well defined group of patients with acute vertebral compression fractures.”

The Vertos II study randomized 202 elderly patients with acute painful vertebral fractures who were treated with either vertebroplasty or conservative care and followed for one year. Conservative care included optimized analgesic regimens, bed rest and physical therapy. According to the authors, “Decrease in VAS score after vertebroplasty was significantly higher than with conservative treatment at all timepoints.” In addition, the vertebroplasty patients, who had significantly more disability and lower quality of life scores at baseline, showed significantly faster and greater improvements than conservatively treated patients for these parameters. The authors concluded that, “Pain relief after the procedure is immediate, sustained for 1 year, and is significantly better than that achieved with conservative treatment and at acceptable costs.” No serious complications or adverse events were reported in the study.

“Contrary to the conclusions published in the NEJM, the results of the Vertos II study show that vertebroplasty is an effective treatment of acute painful osteoporotic fractures in properly selected patients. Important differences between the studies are both the degree of pain and the number of weeks or months that the patients needed to be in pain before being considered for treatment,” said Dr. Maarten Persenaire, Chief Medical Officer of Orthovita. “One of the strengths of the Vertos II study is its applicability in routine care where patients with acute pain first undergo imaging and other tests to diagnose the cause and assess their overall state of health. By the time all results necessary for treatment selection have been received, about half of patients with fractures may have improved enough to warrant continued conservative measures. The study shows the remaining patients stand to gain significant benefits from vertebroplasty.”

About the Company

Orthovita, Inc. is a specialty spine and orthopedic company with a portfolio of orthobiologic and biosurgery products. Our products are based on novel and unique proprietary biomaterials that have innovative mechanisms of action in the body. Our orthobiologic platform offers products for the fusion, regeneration and fixation of human bone. Our biosurgery platform offers products for controlling intra-operative bleeding, also known as hemostasis. Our current fusion and regeneration products are based on our proprietary VitossTM Bone Graft Substitute technology and address the non-structural bone graft market with synthetic, bioactive alternatives to patient- and cadaver-derived bone tissue. CortossTM Bone Augmentation Material, an injectable, polymer composite that mimics the structural characteristics of human bone, provides the basis for our fixation portfolio. Our hemostasis portfolio includes VitagelTM Surgical Hemostat, a proprietary, collagen-based matrix that controls bleeding and facilitates healing, and Vitasure™ Absorbable Hemostat, a plant-based product that can be deployed quickly throughout surgery.

Disclosure Notice

This press release may contain forward-looking statements regarding Orthovita’s current expectations of future events that involve risks and uncertainties, including, without limitation, the demand and market acceptance of our products, and other aspects of our business. Such statements are based on management’s current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements.Factors that may cause such a difference are listed from time to time in reports filed by the Company with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K under the caption "Risk Factors.”Further information about these and other relevant risks and uncertainties may be found in Orthovita’s filings with the SEC, all of which are available from the SEC as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.

Contacts:

Orthovita, Inc.

Nancy C. Broadbent

Senior Vice President and

Chief Financial Officer

610-640-1775 or 800-676-8482

Source: Orthovita, Inc.